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EC number: 947-954-2 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Skin corrosion: The test item is corrosive to skin because the key study demonstrated that occluded contact with the substance for one hour produced severe irritation (erythema scores at 24/48/72 hours ≥ 2.3 in 5/6 animals) and necrosis was observed in three of the six animals within 7 days (US D.O.T regulations and OECD 404). These data were replicated in a supporting study (US D.O.T regulations and OECD 404).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Department of Transportation, Method of Testing Corrosion to Skin
- Version / remarks:
- Federal Register, Vol 41, No 118, Sept 27 1976
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino
- Details on test animals or test system and environmental conditions:
- ANIMALS AND ANIMAL HUSBANDRY
- Rabbits were sourced from Kuiper Rabbitry, Gary, Indiana, USA and were approximately 8-10 weeks old.
- Animals were housed individually in stainless steel cages in a temperature, humidity and light controlled room.
- Rabbits were conditioned for at least three days prior to study initiation.
- Purina Rabbit Chow and water were available ad libitum.
- All animals used for the investigation were considered to be in good health at study initiation. - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours
- Observation period:
- 7 days
- Number of animals:
- Six
- Details on study design:
- COMPOUND ADMINISTRATION
- Three intact sites were prepared on each of the six animals.
- A dose of 0.5 mL of the test article was applied to the occluded sites for contact periods of 3 minutes (site A), 1 hour (site B) and 4 hours (site C).
- At the conclusion of the individual contact periods, any remaining test material was wiped from the site.
- If necrosis was observed at the shorter contact periods the test was considered to be concluded and longer exposure times were not required.
CLINICAL OBSERVATIONS
- Observations for irritation, ulceration and necrosis were performed at the end of each contact period.
- Observations were repeated at 60 minutes for the 3 minute contact time.
- Observations were repeated at 24, 48 and 72 hours following test article application for the 1 and 4-hour contact times.
- Additional readings were continued up to Day 7 to confirm transport packing group
- Corrosion was considered to have resulted if the substance in contact with rabbit skin produced full thickness destruction or irreversible alteration of tissue.
- Tissue destruction was considered to have occurred if ulceration and/or necrosis was observed at any of the readings.
- Tissue destruction did not include merely sloughing of the epidermis, erythema, edema or fissuring.
- Scoring crieria used during evaluation of skin reactions are given in Table 2 (attached). - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 min contact time
- Time point:
- other: 3 min
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks:
- site A
- Remarks on result:
- other:
- Remarks:
- Animals 53, 54, 55, 56, 57 and 58
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 min contact time
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks:
- site A
- Remarks on result:
- other: not corrosive after 3 min contact time
- Remarks:
- Animals 53, 54, 55, 56, 57 and 58
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 1 h contact time
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- site B
- Remarks on result:
- other: Animal 53
- Remarks:
- Necrosis reported at 7 d observation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 1 h contact time
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- site B
- Remarks on result:
- other: Animal 54
- Remarks:
- Score unchanged at 7 d observation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 1 h contact time
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- site B
- Remarks on result:
- other: Animal 55
- Remarks:
- Necrosis reported at 72 h observation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- 1 h contact time
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- site B
- Remarks on result:
- other: Animal 56
- Remarks:
- Score unchanged at 7 d observation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- 1 h contact time
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- site B
- Remarks on result:
- other: Animal 57
- Remarks:
- Score unchanged at 7d observation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- 1 h contact time
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Animal 58
- Remarks:
- Necrosis reported at 7 d observation
- Irritant / corrosive response data:
- - Data showing individual responses of each animal are attached.
- Occluded contact with the test material for three minutes produced no irritation and necrosis was not observed in any of the six animals.
- Occluded contact with the test material for one hour produced severe irritation and necrosis was observed in three of the six animals within 7 days.
- Occluded contact with the test material for four hours caused necrosis in all six animals. - Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Occluded contact with the test item for one hour produced severe irritation (erythema scores at 24/48/72 hours ≥ 2.3 in 5/6 animals) and necrosis was observed in three of the six animals within 7 days. On the basis of this study, the test material is found to be corrosive to skin.
- Executive summary:
In a study performed in accordance with US D.O.T. regulations and OECD 404, the test item was applied to three prepared skin sites on New Zealand White rabbits under occluded conditions for 3 minutes, 1 hour and 4 hours. After the relevant contact period, any remaining test item was wiped from the site. After removal of patches and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored for erythema. No effects were noted over a period of 60 minutes following contact with the test item for 3 minutes. However, occluded contact with the test item for one hour produced severe irritation (erythema scores at 24/48/72 hours ≥ 2.3 in 5/6 animals) and necrosis was observed in three of the six animals within 7 days. On the basis of this study, the test material is found to be corrosive to skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Department of Transportation, Method of Testing Corrosion to Skin
- Version / remarks:
- Federal Register, Vol 41, No 118, Sept 27 1976
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino
- Details on test animals or test system and environmental conditions:
- ANIMALS AND ANIMAL HUSBANDRY
- Rabbits were sourced from Kuiper Rabbitry, Gary, Indiana, USA and were approximately 8-10 weeks old.
- Animals were housed individually in stainless steel cages in a temperature, humidity and light controlled room.
- Rabbits were conditioned for at least three days prior to study initiation.
- Purina Rabbit Chow and water were available ad libitum.
- All animals used for the investigation were considered to be in good health at study initiation. - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours
- Observation period:
- 7 days
- Number of animals:
- Six
- Details on study design:
- COMPOUND ADMINISTRATION
- Three intact sites were prepared on each of the six animals.
- A dose of 0.5 mL of the test article was applied to the occluded sites for contact periods of 3 minutes
(site A), 1 hour (site B) and 4 hours (site C).
- At the conclusion of the individual contact periods, any remaining test material was wiped from the site.
- If necrosis was observed at the shorter contact periods the test was considered to be concluded and
longer exposure times were not required.
CLINICAL OBSERVATIONS
- Observations for irritation, ulceration and necrosis were performed at the end of each contact period.
- Observations were repeated at 60 minutes for the 3 minute contact time.
- Observations were repeated at 24, 48 and 72 hours following test article application for the 1 and 4-
hour contact times.
- Additional readings were continued up to Day 7 to confirm transport packing group
- Corrosion was considered to have resulted if the substance in contact with rabbit skin produced full thick
ness destruction or irreversible alteration of tissue.
- Tissue destruction was considered to have occurred if ulceration and/or necrosis was observed at any of
the readings.
- Tissue destruction did not include merely sloughing of the epidermis, erythema, edema or fissuring.
- Scoring crieria used during evaluation of skin reactions are given in Table 2 (attached). - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 min contact time
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- site A
- Remarks on result:
- other: Animals 49, 50, 51, 53 and 54
- Remarks:
- Score was 3 at 7 d observation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 min contact time
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- site A
- Remarks on result:
- other: Animal 52
- Remarks:
- Score was 3 at 7d observation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 1 h contact time
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- site B
- Remarks on result:
- other: Animals 50, 51 and 54
- Remarks:
- Score was 4 at 7 d observation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 1 h contact time
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- site B
- Remarks on result:
- other: Animals 49, 52 and 53
- Remarks:
- Necrosis was reported at 7 d observation
- Irritant / corrosive response data:
- - Data showing individual responses of each animal are attached.
- Occluded contact with the test material for three minutes produced moderate to severe irritation in all six animals tested. However, necrosis and irreversible damage were not seen.
- Occluded contact with the test material for one hour produced severe irritation in all six animals. Necrosis and full thickness damage was observed in three of the six animals within 7 days.
- Occluded contact with the test material for four hours caused severe irritation in all six animals. Necrosis and full thickness damage was observd in five out of the six animals within 7 days. - Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Severe irreversible skin irritation (6/6 animals) was reported after contact with the test item for 3 minutes and severe skin irritation (6/6 animals) followed by necrosis (3/6 animals) was observed following occluded contact with the test material for one hour.
- Executive summary:
In a study performed in accordance with US D.O.T. regulations and OECD 404, the test item was applied to three prepared skin sites on New Zealand White rabbits under occluded conditions for 3 minutes, 1 hour and 4 hours. After the relevant contact period, any remaining test item was wiped from the site. After removal of patches and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored for erythema. Severe irreversible skin irritation was reported after contact with the test item for 3 minutes (erythema scores ≥ 2.3 in 6/6 animals persisting to the 7 d observation when the score attributed to each animal was 3). Contact with the test item for one hour produced severe irritation (erythema scores at 24/48/72 hours ≥ 2.3 in 6/6 animals) and necrosis was observed in three of the six animals within 7 days. On the basis of this study, the test material is found to be corrosive to skin.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
- Endpoint:
- eye irritation: in vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin corrosion: In a key study performed in accordance with US D.O.T. regulations and OECD 404, the test item was applied to three prepared skin sites on New Zealand White rabbits under occluded conditions for 3 minutes, 1 hour and 4 hours. After the relevant contact period, any remaining test item was wiped from the site. After removal of patches and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored for erythema. No effects were noted over a period of 60 minutes following contact with the test item for 3 minutes. However, occluded contact with the test item for one hour produced severe irritation (erythema scores at 24/48/72 hours ≥ 2.3 in 5/6 animals) and necrosis was observed in three of the six animals within 7 days. On the basis of this study, the test material is found to be corrosive to skin. In a supporting study, conducted in accordance with the same test guidelines, severe irreversible skin irritation was reported after contact with the test item for 3 minutes (erythema scores ≥ 2.3 in 6/6 animals persisting to the 7 d observation when the score attributed to each animal was 3). Contact with the test item for one hour produced severe irritation (erythema scores at 24/48/72 hours ≥ 2.3 in 6/6 animals) and necrosis was observed in three of the six animals within 7 days. This study provides confirmation that the test material is corrosive to skin.
Justification for classification or non-classification
Skin corrosion: The results of two studies reported corrosive responses in at least one animal following exposure > 3 min and ≤ 1 h with observations ≤ 14 days. Classification as Skin Corr 1B is therefore warranted under the terms of Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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